Trial Outcomes & Findings for Long-Term Effectiveness of Walking Training in Patients With Knee Osteoarthritis (NCT NCT02767570)
NCT ID: NCT02767570
Last Updated: 2022-04-15
Results Overview
Change in medial knee pain between baseline and week 52 using an 11-point Numeric Rating Scale (NRS) to assess average medial knee pain over the past 7 day period. Possible scores range from 0 (no pain) to 10 (worst pain imaginable). Change = (Week 52 score - Baseline score).
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
68 participants
Primary outcome timeframe
Baseline and Week 52
Results posted on
2022-04-15
Participant Flow
Participants were recruited via clinician referrals, approved searches of medical record databases, and advertisements in print media and online. The first participant was enrolled in August 2016 and the last participant was enrolled in June 2019.
Interested individuals were initially screened via telephone or web-based questionnaire. Eligible individuals then underwent an in-person screen to confirm the location and severity of knee pain. Anterior-posterior weightbearing radiographs were obtained and given a KL grade. Participants who met the radiographic inclusion criteria were invited to the motion laboratory for a gait assessment. Those who were able to reduce their KAM peak by at least 5% with an FPA modification were randomized.
Participant milestones
| Measure |
Gait Training; Altered Foot Progression Angle
Participants will receive personalized gait training while walking on a treadmill with real-time, haptic feedback. The goal of the training is to encourage participants to adopt an altered foot progression angle in an attempt to alter the distribution of forces crossing the knee joint. Training will occur once a week for six weeks. This will be followed by a 46-week home and community-based walking program to practice and internalize the new personalized, gait pattern and to encourage daily walking. Refresher training with haptic feedback will be offered at weeks 11, 25 and 39 to enhance internalization of the new foot progression angle.
Gait Training; Altered Foot Progression Angle: Participants will receive personalized gait training while walking on a treadmill with real-time, haptic feedback to encourage them to adopt a new foot progression angle. Participants will walk for an additional ten minutes per day to internalize their new foot progression angle over 52 weeks.
|
Gait Training; Consistent Foot Progression Angle
Participants will receive personalized gait training while walking on a treadmill with haptic feedback. The goal of the training is to encourage participants to maintain a consistent foot progression angle in an attempt to minimize the variability in the forces crossing the knee joint. Training will occur once a week, for 6 weeks. This will be followed by a 46-week home and community-based walking program to encourage daily walking. Refresher training with haptic feedback will be offered at weeks 11, 25 and 39 to maintain foot progression angle consistency.
Gait Training; Consistent Foot Progression Angle: Participants will receive personalized gait training while walking on a treadmill with haptic feedback to encourage them to maintain a consistent foot progression angle. Participants will walk an additional ten minutes per day to internalize the consistency of their foot progression angle over 52 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
34
|
34
|
|
Overall Study
Per Protocol Week 6
|
31
|
33
|
|
Overall Study
COMPLETED
|
25
|
24
|
|
Overall Study
NOT COMPLETED
|
9
|
10
|
Reasons for withdrawal
| Measure |
Gait Training; Altered Foot Progression Angle
Participants will receive personalized gait training while walking on a treadmill with real-time, haptic feedback. The goal of the training is to encourage participants to adopt an altered foot progression angle in an attempt to alter the distribution of forces crossing the knee joint. Training will occur once a week for six weeks. This will be followed by a 46-week home and community-based walking program to practice and internalize the new personalized, gait pattern and to encourage daily walking. Refresher training with haptic feedback will be offered at weeks 11, 25 and 39 to enhance internalization of the new foot progression angle.
Gait Training; Altered Foot Progression Angle: Participants will receive personalized gait training while walking on a treadmill with real-time, haptic feedback to encourage them to adopt a new foot progression angle. Participants will walk for an additional ten minutes per day to internalize their new foot progression angle over 52 weeks.
|
Gait Training; Consistent Foot Progression Angle
Participants will receive personalized gait training while walking on a treadmill with haptic feedback. The goal of the training is to encourage participants to maintain a consistent foot progression angle in an attempt to minimize the variability in the forces crossing the knee joint. Training will occur once a week, for 6 weeks. This will be followed by a 46-week home and community-based walking program to encourage daily walking. Refresher training with haptic feedback will be offered at weeks 11, 25 and 39 to maintain foot progression angle consistency.
Gait Training; Consistent Foot Progression Angle: Participants will receive personalized gait training while walking on a treadmill with haptic feedback to encourage them to maintain a consistent foot progression angle. Participants will walk an additional ten minutes per day to internalize the consistency of their foot progression angle over 52 weeks.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
3
|
0
|
|
Overall Study
COVID shutdown
|
2
|
5
|
|
Overall Study
Increased pain
|
2
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
3
|
|
Overall Study
Unrelated medical issue
|
1
|
1
|
|
Overall Study
Received intra-articular injection
|
0
|
1
|
Baseline Characteristics
Long-Term Effectiveness of Walking Training in Patients With Knee Osteoarthritis
Baseline characteristics by cohort
| Measure |
Gait Training; Altered Foot Progression Angle
n=34 Participants
Participants will receive personalized gait training while walking on a treadmill with real-time, haptic feedback. The goal of the training is to encourage participants to adopt an altered foot progression angle in an attempt to alter the distribution of forces crossing the knee joint. Training will occur once a week for six weeks. This will be followed by a 46-week home and community-based walking program to practice and internalize the new personalized, gait pattern and to encourage daily walking. Refresher training with haptic feedback will be offered at weeks 11, 25 and 39 to enhance internalization of the new foot progression angle.
Gait Training; Altered Foot Progression Angle: Participants will receive personalized gait training while walking on a treadmill with real-time, haptic feedback to encourage them to adopt a new foot progression angle. Participants will walk for an additional ten minutes per day to internalize their new foot progression angle over 52 weeks.
|
Gait Training; Consistent Foot Progression Angle
n=34 Participants
Participants will receive personalized gait training while walking on a treadmill with haptic feedback. The goal of the training is to encourage participants to maintain a consistent foot progression angle in an attempt to minimize the variability in the forces crossing the knee joint. Training will occur once a week, for 6 weeks. This will be followed by a 46-week home and community-based walking program to encourage daily walking. Refresher training with haptic feedback will be offered at weeks 11, 25 and 39 to maintain foot progression angle consistency.
Gait Training; Consistent Foot Progression Angle: Participants will receive personalized gait training while walking on a treadmill with haptic feedback to encourage them to maintain a consistent foot progression angle. Participants will walk an additional ten minutes per day to internalize the consistency of their foot progression angle over 52 weeks.
|
Total
n=68 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
64.32 years
STANDARD_DEVIATION 7.66 • n=93 Participants
|
64.53 years
STANDARD_DEVIATION 7.63 • n=4 Participants
|
64.43 years
STANDARD_DEVIATION 7.59 • n=27 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=93 Participants
|
20 Participants
n=4 Participants
|
41 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=93 Participants
|
14 Participants
n=4 Participants
|
27 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
34 Participants
n=93 Participants
|
34 Participants
n=4 Participants
|
68 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
10 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
28 Participants
n=93 Participants
|
26 Participants
n=4 Participants
|
54 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
34 Participants
n=93 Participants
|
34 Participants
n=4 Participants
|
68 Participants
n=27 Participants
|
|
Body Mass Index
|
25.53 kg/m^2
STANDARD_DEVIATION 3.26 • n=93 Participants
|
27.37 kg/m^2
STANDARD_DEVIATION 3.95 • n=4 Participants
|
26.45 kg/m^2
STANDARD_DEVIATION 3.71 • n=27 Participants
|
|
Kellgren-Lawrence classification of knee OA
Grade 1
|
7 Participants
n=93 Participants
|
7 Participants
n=4 Participants
|
14 Participants
n=27 Participants
|
|
Kellgren-Lawrence classification of knee OA
Grade 2
|
14 Participants
n=93 Participants
|
17 Participants
n=4 Participants
|
31 Participants
n=27 Participants
|
|
Kellgren-Lawrence classification of knee OA
Grade 3
|
13 Participants
n=93 Participants
|
10 Participants
n=4 Participants
|
23 Participants
n=27 Participants
|
|
NRS pain, medial
|
4.32 units on a scale
STANDARD_DEVIATION 1.32 • n=93 Participants
|
4.00 units on a scale
STANDARD_DEVIATION 1.21 • n=4 Participants
|
4.16 units on a scale
STANDARD_DEVIATION 1.27 • n=27 Participants
|
|
KAM peak, natural FPA
|
3.25 %Bodyweight*Height
STANDARD_DEVIATION 1.05 • n=93 Participants
|
3.30 %Bodyweight*Height
STANDARD_DEVIATION 1.05 • n=4 Participants
|
3.27 %Bodyweight*Height
STANDARD_DEVIATION 1.04 • n=27 Participants
|
|
KAM peak, target FPA
|
2.87 %Bodyweight*Height
STANDARD_DEVIATION 1.05 • n=93 Participants
|
3.30 %Bodyweight*Height
STANDARD_DEVIATION 1.05 • n=4 Participants
|
3.08 %Bodyweight*Height
STANDARD_DEVIATION 1.06 • n=27 Participants
|
|
WOMAC pain
|
70.74 units on a scale
STANDARD_DEVIATION 12.86 • n=93 Participants
|
71.21 units on a scale
STANDARD_DEVIATION 11.18 • n=4 Participants
|
70.97 units on a scale
STANDARD_DEVIATION 11.97 • n=27 Participants
|
|
WOMAC function
|
75.74 units on a scale
STANDARD_DEVIATION 14.23 • n=93 Participants
|
73.17 units on a scale
STANDARD_DEVIATION 13.06 • n=4 Participants
|
74.45 units on a scale
STANDARD_DEVIATION 13.62 • n=27 Participants
|
|
Daily steps
|
6343 steps/day
STANDARD_DEVIATION 2678 • n=93 Participants
|
6280 steps/day
STANDARD_DEVIATION 3073 • n=4 Participants
|
6311 steps/day
STANDARD_DEVIATION 2860 • n=27 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 52Population: Intent-to-treat population. Missing data were imputed using the Markov chain Monte Carlo method for continuous variables.
Change in medial knee pain between baseline and week 52 using an 11-point Numeric Rating Scale (NRS) to assess average medial knee pain over the past 7 day period. Possible scores range from 0 (no pain) to 10 (worst pain imaginable). Change = (Week 52 score - Baseline score).
Outcome measures
| Measure |
Gait Training; Altered Foot Progression Angle
n=34 Participants
Participants will receive personalized gait training while walking on a treadmill with real-time, haptic feedback. The goal of the training is to encourage participants to adopt an altered foot progression angle in an attempt to alter the distribution of forces crossing the knee joint. Training will occur once a week for six weeks. This will be followed by a 46-week home and community-based walking program to practice and internalize the new personalized, gait pattern and to encourage daily walking. Refresher training with haptic feedback will be offered at weeks 11, 25 and 39 to enhance internalization of the new foot progression angle.
Gait Training; Altered Foot Progression Angle: Participants will receive personalized gait training while walking on a treadmill with real-time, haptic feedback to encourage them to adopt a new foot progression angle. Participants will walk for an additional ten minutes per day to internalize their new foot progression angle over 52 weeks.
|
Gait Training; Consistent Foot Progression Angle
n=34 Participants
Participants will receive personalized gait training while walking on a treadmill with haptic feedback. The goal of the training is to encourage participants to maintain a consistent foot progression angle in an attempt to minimize the variability in the forces crossing the knee joint. Training will occur once a week, for 6 weeks. This will be followed by a 46-week home and community-based walking program to encourage daily walking. Refresher training with haptic feedback will be offered at weeks 11, 25 and 39 to maintain foot progression angle consistency.
Gait Training; Consistent Foot Progression Angle: Participants will receive personalized gait training while walking on a treadmill with haptic feedback to encourage them to maintain a consistent foot progression angle. Participants will walk an additional ten minutes per day to internalize the consistency of their foot progression angle over 52 weeks.
|
|---|---|---|
|
Change in Medial Knee Pain
|
-2.5 score on a scale
Standard Deviation 2.2
|
-1.3 score on a scale
Standard Deviation 2.3
|
PRIMARY outcome
Timeframe: Baseline and Week 52Population: Intent-to-treat population. Missing data were imputed using the Markov chain Monte Carlo method for continuous variables.
Change in magnitude of the more prominent peak in the knee adduction moment (KAM), a surrogate measure for medio-lateral load distribution in the knee, between baseline and week 52. A reduction in KAM indicates a shift in loading from the medial to the lateral compartment of the knee. Change = (Week 52 - Baseline).
Outcome measures
| Measure |
Gait Training; Altered Foot Progression Angle
n=34 Participants
Participants will receive personalized gait training while walking on a treadmill with real-time, haptic feedback. The goal of the training is to encourage participants to adopt an altered foot progression angle in an attempt to alter the distribution of forces crossing the knee joint. Training will occur once a week for six weeks. This will be followed by a 46-week home and community-based walking program to practice and internalize the new personalized, gait pattern and to encourage daily walking. Refresher training with haptic feedback will be offered at weeks 11, 25 and 39 to enhance internalization of the new foot progression angle.
Gait Training; Altered Foot Progression Angle: Participants will receive personalized gait training while walking on a treadmill with real-time, haptic feedback to encourage them to adopt a new foot progression angle. Participants will walk for an additional ten minutes per day to internalize their new foot progression angle over 52 weeks.
|
Gait Training; Consistent Foot Progression Angle
n=34 Participants
Participants will receive personalized gait training while walking on a treadmill with haptic feedback. The goal of the training is to encourage participants to maintain a consistent foot progression angle in an attempt to minimize the variability in the forces crossing the knee joint. Training will occur once a week, for 6 weeks. This will be followed by a 46-week home and community-based walking program to encourage daily walking. Refresher training with haptic feedback will be offered at weeks 11, 25 and 39 to maintain foot progression angle consistency.
Gait Training; Consistent Foot Progression Angle: Participants will receive personalized gait training while walking on a treadmill with haptic feedback to encourage them to maintain a consistent foot progression angle. Participants will walk an additional ten minutes per day to internalize the consistency of their foot progression angle over 52 weeks.
|
|---|---|---|
|
Change in Knee Adduction Moment
|
-0.17 %Bodyweight*Height
Standard Deviation 0.47
|
0.08 %Bodyweight*Height
Standard Deviation 0.33
|
SECONDARY outcome
Timeframe: Baseline and Week 52Population: Intent-to-treat population. Missing data were imputed using the Markov chain Monte Carlo method for continuous variables.
Change in T1rho relaxation time measured from quantitative MRI in the medial compartment of the knee between baseline and week 52. T1ρ relaxation time is sensitive to changes in proteoglycan content in the articular cartilage. Increased values of T1rho indicate increased depletion of proteoglycans and increased cartilage degeneration. Change = (Week 52 - Baseline).
Outcome measures
| Measure |
Gait Training; Altered Foot Progression Angle
n=34 Participants
Participants will receive personalized gait training while walking on a treadmill with real-time, haptic feedback. The goal of the training is to encourage participants to adopt an altered foot progression angle in an attempt to alter the distribution of forces crossing the knee joint. Training will occur once a week for six weeks. This will be followed by a 46-week home and community-based walking program to practice and internalize the new personalized, gait pattern and to encourage daily walking. Refresher training with haptic feedback will be offered at weeks 11, 25 and 39 to enhance internalization of the new foot progression angle.
Gait Training; Altered Foot Progression Angle: Participants will receive personalized gait training while walking on a treadmill with real-time, haptic feedback to encourage them to adopt a new foot progression angle. Participants will walk for an additional ten minutes per day to internalize their new foot progression angle over 52 weeks.
|
Gait Training; Consistent Foot Progression Angle
n=34 Participants
Participants will receive personalized gait training while walking on a treadmill with haptic feedback. The goal of the training is to encourage participants to maintain a consistent foot progression angle in an attempt to minimize the variability in the forces crossing the knee joint. Training will occur once a week, for 6 weeks. This will be followed by a 46-week home and community-based walking program to encourage daily walking. Refresher training with haptic feedback will be offered at weeks 11, 25 and 39 to maintain foot progression angle consistency.
Gait Training; Consistent Foot Progression Angle: Participants will receive personalized gait training while walking on a treadmill with haptic feedback to encourage them to maintain a consistent foot progression angle. Participants will walk an additional ten minutes per day to internalize the consistency of their foot progression angle over 52 weeks.
|
|---|---|---|
|
Change in Medial T1rho Relaxation Time
|
-1.72 ms
Standard Deviation 5.68
|
2.02 ms
Standard Deviation 5.53
|
SECONDARY outcome
Timeframe: Baseline and Week 52Population: Intent-to-treat population. Missing data were imputed using the Markov chain Monte Carlo method for continuous variables.
Change in T2 relaxation time measured from quantitative MRI in the medial compartment of the knee between baseline and week 52. T2 relaxation time is sensitive to changes in water content and collagen matrix integrity of the articular cartilage. Increased values of T2 indicate increased cartilage degeneration. Change = (Week 52 - Baseline).
Outcome measures
| Measure |
Gait Training; Altered Foot Progression Angle
n=34 Participants
Participants will receive personalized gait training while walking on a treadmill with real-time, haptic feedback. The goal of the training is to encourage participants to adopt an altered foot progression angle in an attempt to alter the distribution of forces crossing the knee joint. Training will occur once a week for six weeks. This will be followed by a 46-week home and community-based walking program to practice and internalize the new personalized, gait pattern and to encourage daily walking. Refresher training with haptic feedback will be offered at weeks 11, 25 and 39 to enhance internalization of the new foot progression angle.
Gait Training; Altered Foot Progression Angle: Participants will receive personalized gait training while walking on a treadmill with real-time, haptic feedback to encourage them to adopt a new foot progression angle. Participants will walk for an additional ten minutes per day to internalize their new foot progression angle over 52 weeks.
|
Gait Training; Consistent Foot Progression Angle
n=34 Participants
Participants will receive personalized gait training while walking on a treadmill with haptic feedback. The goal of the training is to encourage participants to maintain a consistent foot progression angle in an attempt to minimize the variability in the forces crossing the knee joint. Training will occur once a week, for 6 weeks. This will be followed by a 46-week home and community-based walking program to encourage daily walking. Refresher training with haptic feedback will be offered at weeks 11, 25 and 39 to maintain foot progression angle consistency.
Gait Training; Consistent Foot Progression Angle: Participants will receive personalized gait training while walking on a treadmill with haptic feedback to encourage them to maintain a consistent foot progression angle. Participants will walk an additional ten minutes per day to internalize the consistency of their foot progression angle over 52 weeks.
|
|---|---|---|
|
Change in Medial T2 Relaxation Time
|
-0.58 ms
Standard Deviation 2.65
|
-0.52 ms
Standard Deviation 3.11
|
SECONDARY outcome
Timeframe: Baseline and Week 52Population: Intent-to-treat population. Missing data were imputed using the Markov chain Monte Carlo method for continuous variables.
Change in T1rho relaxation time measured from quantitative MRI in the lateral compartment of the knee between baseline and week 52. T1ρ relaxation time is sensitive to changes in proteoglycan content in the articular cartilage. Increased values of T1rho indicate increased depletion of proteoglycans and increased cartilage degeneration. Change = (Week 52 - Baseline).
Outcome measures
| Measure |
Gait Training; Altered Foot Progression Angle
n=34 Participants
Participants will receive personalized gait training while walking on a treadmill with real-time, haptic feedback. The goal of the training is to encourage participants to adopt an altered foot progression angle in an attempt to alter the distribution of forces crossing the knee joint. Training will occur once a week for six weeks. This will be followed by a 46-week home and community-based walking program to practice and internalize the new personalized, gait pattern and to encourage daily walking. Refresher training with haptic feedback will be offered at weeks 11, 25 and 39 to enhance internalization of the new foot progression angle.
Gait Training; Altered Foot Progression Angle: Participants will receive personalized gait training while walking on a treadmill with real-time, haptic feedback to encourage them to adopt a new foot progression angle. Participants will walk for an additional ten minutes per day to internalize their new foot progression angle over 52 weeks.
|
Gait Training; Consistent Foot Progression Angle
n=34 Participants
Participants will receive personalized gait training while walking on a treadmill with haptic feedback. The goal of the training is to encourage participants to maintain a consistent foot progression angle in an attempt to minimize the variability in the forces crossing the knee joint. Training will occur once a week, for 6 weeks. This will be followed by a 46-week home and community-based walking program to encourage daily walking. Refresher training with haptic feedback will be offered at weeks 11, 25 and 39 to maintain foot progression angle consistency.
Gait Training; Consistent Foot Progression Angle: Participants will receive personalized gait training while walking on a treadmill with haptic feedback to encourage them to maintain a consistent foot progression angle. Participants will walk an additional ten minutes per day to internalize the consistency of their foot progression angle over 52 weeks.
|
|---|---|---|
|
Change in Lateral T1rho Relaxation Time
|
-1.11 ms
Standard Deviation 6.07
|
-0.83 ms
Standard Deviation 6.80
|
SECONDARY outcome
Timeframe: Baseline and Week 52Population: Intent-to-treat population. Missing data were imputed using the Markov chain Monte Carlo method for continuous variables.
Change in T2 relaxation time measured from quantitative MRI in the lateral compartment of the knee between baseline and week 52. T2 relaxation time is sensitive to changes in water content and collagen matrix integrity of the articular cartilage. Increased values of T2 indicate increased cartilage degeneration. Change = (Week 52 - Baseline).
Outcome measures
| Measure |
Gait Training; Altered Foot Progression Angle
n=34 Participants
Participants will receive personalized gait training while walking on a treadmill with real-time, haptic feedback. The goal of the training is to encourage participants to adopt an altered foot progression angle in an attempt to alter the distribution of forces crossing the knee joint. Training will occur once a week for six weeks. This will be followed by a 46-week home and community-based walking program to practice and internalize the new personalized, gait pattern and to encourage daily walking. Refresher training with haptic feedback will be offered at weeks 11, 25 and 39 to enhance internalization of the new foot progression angle.
Gait Training; Altered Foot Progression Angle: Participants will receive personalized gait training while walking on a treadmill with real-time, haptic feedback to encourage them to adopt a new foot progression angle. Participants will walk for an additional ten minutes per day to internalize their new foot progression angle over 52 weeks.
|
Gait Training; Consistent Foot Progression Angle
n=34 Participants
Participants will receive personalized gait training while walking on a treadmill with haptic feedback. The goal of the training is to encourage participants to maintain a consistent foot progression angle in an attempt to minimize the variability in the forces crossing the knee joint. Training will occur once a week, for 6 weeks. This will be followed by a 46-week home and community-based walking program to encourage daily walking. Refresher training with haptic feedback will be offered at weeks 11, 25 and 39 to maintain foot progression angle consistency.
Gait Training; Consistent Foot Progression Angle: Participants will receive personalized gait training while walking on a treadmill with haptic feedback to encourage them to maintain a consistent foot progression angle. Participants will walk an additional ten minutes per day to internalize the consistency of their foot progression angle over 52 weeks.
|
|---|---|---|
|
Change in Lateral T2 Relaxation Time
|
-0.02 ms
Standard Deviation 2.14
|
-0.02 ms
Standard Deviation 1.88
|
Adverse Events
Gait Training; Altered Foot Progression Angle
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Gait Training; Consistent Foot Progression Angle
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place